Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer
- Men over 18 years of age;
- Diagnosed with prostate cancer and eligible for active surveillance;
- No prior treatment for prostate cancer;
- Prostate Cancer Stage up to cT2b - N0/Nx - M0/Mx (rT2c and pT2c are acceptable)
- Gleason score ≤ 3+3 For patients characterized with prostate mapping (transperineal
template guided biopsy at 5mm intervals) a secondary pattern 4 is acceptable provided
that it is not present in more than 3 cores from each side of the prostate and is no
more than 3 mm cancer core length.
- PSA < 10 ng/mL;
- Signed Informed Consent Form.
- Any condition or history of illness or surgery that, in the opinion of the
investigator and/or the Sponsor, might confound the results of the study or pose
additional risks to the patient.
- All patients whose current pre-operative cardiac evaluation does not show their
fitness for a procedure requiring general anesthesia;
- Patients with a prior history of viral or alcoholic hepatitis, and other patients
felt to be at risk for hepatotoxicity including concomitant use of potentially
hepatotoxic medications or dietary supplements;
- Patients with a history of inflammatory bowel disease or other factors which may
increase the risk of fistula formation;
- Men who have received any hormonal manipulation (excluding 5-alpha reductase
inhibitors) or androgen supplements within the previous 6 months;
- Men previously treated by radiation therapy (external therapy or brachytherapy) or
chemotherapy or any therapy for prostate cancer;
- Men who have received or are receiving chemotherapy for prostate carcinoma or other
- Men who have undergone previous TURP (trans-urethral resection of the prostate);
- Men who are currently receiving any medications having potential photosensitizing
effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic
agents, thiazide diuretics and griseofulvin).
- Men who are receiving anticoagulant drugs (e.g.: coumadin, warfarin).
- Patient who stopped long term treatment of acetylsalicylic acid (aspirin) or other
anti platelets agents less than 15 days before the procedure;
- Patient suspected of Disseminated Intravascular Coagulation (DIC) as defined by the
presence of three out of the five following criteria: platelets ULN, aPTT
- History of non compliance with medical therapy and medical recommendations or an
unwillingness or inability to complete patient self-administered questionnaires;
- Participation in a clinical study or receipt of an investigational treatment within
the past 3 months;
- A history of porphyria;
- A history of sun hypersensitivity or photosensitive dermatitis;
- Renal disorders (blood creatinine > 1.5 x ULN) or known post mictional residue >
- Hepatic disorders (transaminases > ULN, bilirubin > ULN,). In case of slight
abnormalities, another exam should be performed. If the results are within normal
ranges, then the patient can be included;
- Hematological disorders (white cells < 2500/mm3, neutrophils < 1500/mm3, platelets <
140.000/mm3, Hb < 8 g/dL);
- Patient with contra-indication to MRI (such as pace maker, metal prosthesis, etc.).